Part I: Consumer Reports Official Advocates for Warranties on Medical Devices

Welcome to a special two-part podcast featuring Lisa McGiffert, director of Consumers Union’s Safe Patient Project, the policy arm of Consumer Reports, a publication trusted for its integrity and dedication to the best interests of the American consumer.

On this episode, McGiffert phoned in from Safe Patient’s offices in Austin, Texas to talk about their mission and a new revolutionary campaign to get manufacturers of hip and knee implants to warranty their products.

After all, if cars and other products are warrantied, why shouldn’t companies provide warranties for medical devices implanted in humans?

Some of the most troublesome devices are metal-on-metal hip implants. These devices have the highest premature failure rates, and more than 750,000 Americans received these implants over the last decade.

Hip implant manufacturers now face a deluge of lawsuits filed by people who suffered complications from failed devices. Injuries range from infections and dislocations to bone and tissue damage that requires multiple revision surgeries to correct.

Safe Patient proposes that a warranty will hold manufacturers accountable, make products safer and help patients handle the costs of replacing the device.

Learn more about hip replacement lawsuits

‘End Secrecy, Save Lives’

The Safe Patient Project has spent the last decade enacting key legislation that protects patients and makes information more accessible to the public, allowing them to make better decisions about their health.

Its mission: End secrecy, save lives.

McGiffert says Safe Patient advocates for patients and endeavors to prevent medical harm by educating the public.

The campaign sets itself apart by working hand-in-hand with people who suffered medical harm from dangerous medical devices, hospital negligence and other causes. Through its dedicated national network of activists, Safe Patient crusades to make health care safer for everyone.

They also work closely with the health ratings system of Consumer Reports, publishing information about infection rates in hospitals, how patients fare after treatment in hospitals and error rates of surgeons and other physicians.

In September, the advocates at Safe Patient rolled out their latest campaign focused on warranties for hip and knee implants to improve the safety of these devices and educate the public.

“Patients have a right to know how long medical device manufacturers are willing to stand by their products,” said McGiffert. “While patients may be told by their surgeon how long a device can be expected to last, they rarely get a guarantee in writing since most hip and knee implants do not come with a warranty.”

Why Should Hip and Knee Implants Carry Warranties?

Doctors perform nearly a million hip and knee and hip replacement surgeries a year, and the surgery is becoming more common as the aging population grows.

The majority of hip and knee implants, especially newer models, have an improved design that makes them safer and more durable than older models. However, when these implants fail, they cause problems that affect a patient’s physical, emotional and financial health.

Currently, the patient and their insurance company have to deal with the cost when the implants fail.

“These implants are being used in younger and younger patients. If you are 40 years old when you get your first implant, and it only lasts 10 years, you may have to have four or five revisions. Each revision is going to get more and more difficult,” McGiffert said. “These are things that people need to consider when they are thinking about getting an implant.”

Even people who don’t have these implants suffer consequences.

American taxpayers contribute to Medicare and foot the bill for these faulty devices to be replaced in patients over age 65. According to Safe Patient, the average cost of hip replacement surgery is $19,000. Revision surgery, a more complex procedure, can cost thousands more.

Here is another little known fact: Most of these devices are not tested for safety before being implanted in patients.

The Food and Drug Administration’s 510(k) approval process only requires manufacturers to say their device is “substantially similar” to another device previously on the market before they are allowed to sell it.

“This is the way the market works,” McGiffert said. “So there are a lot of unknowns going in. A lot of the patients we’ve talked to don’t even know what specific device they have.”

Making matters worse, there is no standardized system for notifying patients and doctors during a recall because the devices are not tracked.

What Should a Warranty Include?

The Safe Patient website details points of an ideal warranty program:

• Cover the implant for at least 20 years.
• Cover the full replacement costs of a flawed device, including the device, surgeon, and hospital costs, as well as the related patient out-of-pocket costs.
• Give the consumer the option to replace the failed device with another manufacturer’s product if the implant has been recalled by the FDA or the company, is subject to FDA warnings, is under investigation by the FDA, or if the product is no longer being sold by the company.
• Establish a clear communications system for patients to use, including a toll-free number and a registration number to track the claims process. Physicians will charge the device company, not the patient.
• Not require the patient pay out-of-pocket expenses. For example, the patient should not have to pay the device maker or surgeon first, and get reimbursed later.
• Provide the patient with full information concerning a warranty claim denial and a process to allow the patient to appeal the decision.
• Not limit or eliminate a patient’s right to sue if they use the warranty.
• Not disqualify patients across the board if they have specific diseases or illnesses not related to the failure of a device.
• Not disqualify patients for normal activities, including falls.
• Not disqualify patients due to information that is not routinely available to them, such as information that is on the device packaging or placed into their medical records.

Join us on the next episode of Drugwatch Radio for Part 2 of this series.